Bortezomib and Gemcitabine in Treating Patients With Recurrent or Metastatic Nasopharyngeal Cancer

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This phase II trial is studying how well giving bortezomib together with gemcitabine works in treating patients with recurrent or metastatic nasopharyngeal cancer. Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bortezomib together with gemcitabine may kill more tumor cells

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Bortezomib; Gemcitabine

Criteria

Inclusion Criteria:

• Histologically confirmed nasopharyngeal carcinoma (NPC) of one of the following subtypes:

• Non-keratinizing (WHO type II)

• Undifferentiated (WHO type III)

• Disease meets one of the following stage criteria:

• Stage IVC at diagnosis

• Persisted, metastasized, or recurred after definitive surgery, radiotherapy, and/or chemotherapy

• Measurable disease

• If only measurable disease is within a prior radiation therapy port, disease progression must be clearly demonstrated

• No known CNS metastases

• Serum creatinine ≤ 1.5 times upper limit of normal (ULN) OR creatinine clearance ≥ 60 mL/min

• Absolute neutrophil count ≥ 1,500/mm³

• Platelet count ≥ 100,000/mm³

• Bilirubin normal

• SGOT or SGPT ≤ 2.5 times ULN

• Zubrod performance status 0-2

• No peripheral neuropathy > grade 1

• No prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the patient has been disease-free for 5 years

• Not pregnant or nursing

• Fertile patients must use effective contraception

• More than 6 months since prior myocardial infarction

• No New York Heart Association class III or IV cardiac problems

• No uncontrolled angina

• No severe uncontrolled ventricular arrhythmias

• No acute ischemia by ECG

• No active conduction system abnormalities

• No known hypersensitivity to bortezomib, boron, or mannitol

• See Disease Characteristics

• No prior therapy with gemcitabine hydrochloride, bortezomib, or other proteasome inhibitors

• No more than 28 days since discontinuation of single-agent bortezomib

• Patients with prior gemcitabine hydrochloride treatment are eligible for single-agent bortezomib treatment but NOT for combination treatment

• No more than one prior chemotherapy regimen for the treatment of metastatic or recurrent NPC

• At least 28 days since prior treatment and recovered

• At least 24 weeks since prior adjuvant chemotherapy

• At least 24 weeks since prior chemotherapy as a radiosensitizer for initial locally advanced disease

• At least 28 days since prior radiotherapy and recovered

• At least 28 days since prior surgery and recovered

• No other concurrent therapy for NPC, including any of the following:

• Radiotherapy

• Chemotherapy

• Immunotherapy

• Biologic therapy

• Other investigational drugs

• Gene therapy

• No colony-stimulating factor therapy during the first course of study therapy

• No concurrent highly active antiretroviral therapy (HAART) in HIV-positive patients